MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

The meter and strips have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." initial reporter occupation was patient/consumer.

Event Description

The initial reporter allegedly received questionable results from the coaguchek xs meter serial number (b)(4).At 10:35 am, the result was allegedly 3.5 inr.At around 1:30 pm, the result from a laboratory using an unknown reagent was allegedly 2.5 inr.The therapeutic range was 2.0-3.0 inr and normally tests every 2-3 weeks.

Manufacturer Narrative

The patient allegedly had two scheduled dermatological procedures for squamous cell skin cancer.The first one on an unknown date was allegedly performed on the patient and there were no reported issues.The second scheduled procedure on (b)(6) 2022 was reported to be a more invasive procedure and was the one that was reportedly deferred.

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1¿ 6.8 inr): qc 1: 5.0 inr.Qc 2: 5.0 inr.Qc 3: 5.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.Medwatch fields d9 and h3 were updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16162302
• MDR Text Key: 308752025
• Report Number: 1823260-2023-00138
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 62216023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "EYE VITAMINS".; BRIMONADINE EYEDROPS.; BROCKLATAN EYE DROP.; DORZOLAMIDE EYEDROPS.; DULCOSET SODIUM.; FURSODEMIDE.; LEVOTHYROXINE.; SPIRONOLACTONE.; TRIAMTHINOLONE SKIN CREAM.; WARFARIN.
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 86 KG